(TAPSE): Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Excursion

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06105866
Collaborator
(none)
100
1
6
16.6

Study Details

Study Description

Brief Summary

The aim of our study is to try to establish a relationship between preoperative fasting-related volume changes and tricuspid annular plane systolic excursion (TAPSE), and to determine whether there are changes in right ventricular functions due to preoperative fasting.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Tricuspid Annular Plane Systolic Excursion

Detailed Description

TAPSE (Tricuspid Annular Plane Systolic Excursion) is a parameter that easily measures apex-base shortening and provides specific information about global right ventricular (RV) function. It is less dependent on optimal image quality and serves as an easily measurable criterion compared to other RV function measurements. In this study, one day before the operation, transthoracic echocardiography (TTE) will be conducted on fasting patients, and if the preoperative fasting duration is appropriate on the day of the surgery, TTE measurements will be repeated and recorded. The study aims to evaluate the relationship between TAPSE and volume and determine whether there are any changes in right ventricular functions due to preoperative fasting.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Excursion (TAPSE)
Anticipated Study Start Date :
Oct 18, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Apr 18, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients without Cardiac Disease

Patients between the ages of 18-65 with sinus rhythm, and without valvular disease, pulmonary hypertension, acute myocardial infarction, dilated, and hypertrophic cardiomyopathy will be included in the study.

Diagnostic Test: Tricuspid Annular Plane Systolic Excursion
Transthoracic echocardiography will be performed on patients during hospitalization and preoperatively to investigate the relationship between preoperative fasting and right ventricular functions. This will be examined by looking at TAPSE

Outcome Measures

Primary Outcome Measures

  1. The TAPSE value is related to volume [Patients who apply to our hospital for surgery within 6 months will be included in our study. Preoperative TAPSE measurements will be taken from the patients twice, first during admission and immediately before the operation]

    We will measure FAC, S' velocity, TAPSE, and Myocardial Performance Index (MPI) derived from TDI to evaluate Right Ventricular (RV) systolic functions. To assess the RV diastolic function, we will measure Tricuspid E and A wave velocities, E/A ratio, and E' velocity. TAPSE will be calculated by placing an M-mode cursor along the Tricuspid Annulus and measuring the longitudinal excursion during peak systole

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • ASA 1-2-3

  • The patient must be between 18 and 65 years old.

  • Perioperative hydration has not been administered.

  • Preoperative sedatives have not been given.

  • There should be no known heart disease.

Exclusion Criteria:
  • The patient being pregnant

  • Post-cardiac surgery

  • Severe pulmonary hypertension

  • Severe valve disease

  • Hypertrophic or dilated cardiomyopathy

  • Presence of acute myocardial infarction

  • Non-sinus rhythm

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sevil Gulasti Aydın Zafer Turkey 09010

Sponsors and Collaborators

  • Aydin Adnan Menderes University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sevil Gulastı, Assistant Professor, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier:
NCT06105866
Other Study ID Numbers:
  • NCT093509350935
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sevil Gulastı, Assistant Professor, Aydin Adnan Menderes University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2023